510(k) Report

510(k) · Cleared

Cleared

Smith & Nephew Rail System

K090926510(k) TraditionalCleared Jun 8, 200967-day reviewClass II21 CFR 888.3030

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Smith & Nephew, Inc. · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Cleared on Jun 8, 2009 as substantially equivalent to K994143 (Smith & Nephew, Inc., 2000) and 4 other predicates after a 67-day review. Its family tree reaches back 2 generations to 1980. 10 later devices descend from it.

Decided
Jun 8, 2009
Review
67 days
Class
Class II
Product code
KTT
Recalls
None
Predicates
5

Its longest line of descent runs back 2 generations to K802814 (1980). 7 ancestors in all. 10 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2008: 1 other ancestor2000: 1 other ancestor1997: 1 other ancestor1995: 1 other ancestor1987: 1 other ancestor2012: 1 descendant cleared2020: 2 descendants cleared2025: 4 descendants cleared2026: 2 descendants cleared2024: 1 descendant clearedK802814 · Orthofix Axialexternal Fixation Sys. · Cintor Orthopaedic Div. · 1980K970751 · Heidelberg External Fixator · Smith & Nephew, Inc., Orthopaedic Div. · 199719801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors2 generations back: 1 other ancestor 1 generation forward: 3 descendants2 generations forward: 6 descendants3 generations forward: 1 descendant K970751 · Heidelberg External Fixator · Smith & Nephew, Inc., Orthopaedic Div. · 1997K802814 · Orthofix Axialexternal Fixation Sys. · Cintor Orthopaedic Div. · 19800
  1. Root · 2 generations backK802814 Orthofix Axialexternal Fixation Sys.Cintor Orthopaedic Div. · 1980
  2. 1 generation backK970751 Heidelberg External FixatorSmith & Nephew, Inc., Orthopaedic Div. · 1997
  3. This deviceK090926 Smith & Nephew Rail SystemSmith & Nephew, Inc. · 2009
  4. Descendant · cites it directly · 6 of its ownK120871 Smith & Nephew, Inc. External Fixation System InstrumentationSmith & Nephew, Inc. · 2012
  5. Descendant · cites it directly · 5 of its ownK201253 Modular Rail System, TAYLOR SPATIAL FRAME External Fixator, JET-X…Smith & Nephew · 2020
  6. Descendant · cites it directly · 2 of its ownK200518 Pitkar External Fixation System - Rail MechanismS.H.Pitkar Orthotools Pvt., Ltd. · 2020
  7. Descendant · 2 generations on · 1 of its ownK241563 Extremity Medical External Fixation SystemExtremity Medical, LLC · 2025
  8. Descendant · 2 generations on · 1 of its ownK241357 XT3 SystemBiodynamik, Inc. · 2025

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2012: 12020: 22024: 12025: 42026: 2
2012high 4 (2025) · low 0 (2013)2026

Most influential descendants

Showing 5 of 10 · See all
  • K120871Smith & Nephew, Inc. External Fixation System InstrumentationSmith & Nephew, Inc. · 2012 · cites it directly6descendants
  • K201253Modular Rail System, TAYLOR SPATIAL FRAME External Fixator, JET-X Fixator, ILIZAROV…Smith & Nephew · 2020 · cites it directly5descendants
  • K200518Pitkar External Fixation System - Rail MechanismS.H.Pitkar Orthotools Pvt., Ltd. · 2020 · cites it directly2descendants
  • K241563Extremity Medical External Fixation SystemExtremity Medical, LLC · 2025 · 2 generations on1descendant
  • K241357XT3 SystemBiodynamik, Inc. · 2025 · 2 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K802814Orthofix Axialexternal Fixation Sys.Cintor Orthopaedic Div.1980—
−1K970751Heidelberg External FixatorSmith & Nephew, Inc., Orthopaedic Div.1997—
0 (this device)K090926Smith & Nephew Rail SystemSmith & Nephew, Inc.2009—
+1K120871Smith & Nephew, Inc. External Fixation System InstrumentationSmith & Nephew, Inc.2012—
+1K201253Modular Rail System, TAYLOR SPATIAL FRAME External Fixator, JET-X Fixator…Smith & Nephew2020—
+1K200518Pitkar External Fixation System - Rail MechanismS.H.Pitkar Orthotools Pvt., Ltd.2020—
+2K241563Extremity Medical External Fixation SystemExtremity Medical, LLC2025—
+2K241357XT3 SystemBiodynamik, Inc.2025—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198710
199510
199710
200010
200810

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201210
202020
202410
202540
202620
FIG. 1 — Lineage of K090926, 1980–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in KTT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new KTT device

  1. #1 K242861 TrueLok Elevatescore 21.3 · 14 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (5)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K994143Smith & Nephew External Fixation System [Unilateral (Linear) & Multilateral (Circular)…
Summary page 1
…n design features and overall indications for use. * Smith & Nephew External Fixation System - Unilateral(Linear) & Multilateral (Circular)Fixators and Accessories - K994143 * Taylor Spatial Frame External Fixation System - K970748 · Heidelberg External Fixator - K970751 · Jet-X Bar System Clamps…
Smith & Nephew, Inc.200019
*K970748Taylor Spatial Frame External Fixation System
Summary page 1
…Nephew External Fixation System - Unilateral(Linear) & Multilateral (Circular)Fixators and Accessories - K994143 * Taylor Spatial Frame External Fixation System - K970748 · Heidelberg External Fixator - K970751 · Jet-X Bar System Clamps, Bar and Posts - MR Conditional - K072212 * Hex-Fix Field…
Smith & Nephew, Inc., Orthopaedic Div.1997—
*K970751Heidelberg External Fixator
Summary page 1
…ral(Linear) & Multilateral (Circular)Fixators and Accessories - K994143 * Taylor Spatial Frame External Fixation System - K970748 · Heidelberg External Fixator - K970751 · Jet-X Bar System Clamps, Bar and Posts - MR Conditional - K072212 * Hex-Fix Field External Fixator - K953397…
Smith & Nephew, Inc., Orthopaedic Div.1997—
*K072212Jet-X Bar System Clamps, Bars and Posts-MR Safe
Summary page 1
…94143 * Taylor Spatial Frame External Fixation System - K970748 · Heidelberg External Fixator - K970751 · Jet-X Bar System Clamps, Bar and Posts - MR Conditional - K072212 * Hex-Fix Field External Fixator - K953397…
Smith & Nephew, Inc.2008—
*K953397Hex-Fix Field Fixator
Summary page 1
…ion System - K970748 · Heidelberg External Fixator - K970751 · Jet-X Bar System Clamps, Bar and Posts - MR Conditional - K072212 * Hex-Fix Field External Fixator - K953397 Page 1 of 1 k4…
Smith & Nephew Richards, Inc.1995—

Also cleared against K994143: 18 other devices →

What descends from it? (10)

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K120871Smith & Nephew, Inc. External Fixation System InstrumentationSmith & Nephew, Inc.20126
K201253Modular Rail System, TAYLOR SPATIAL FRAME External Fixator, JET-X Fixator, ILIZAROV…Smith & Nephew20205
K200518Pitkar External Fixation System - Rail MechanismS.H.Pitkar Orthotools Pvt., Ltd.20202

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 29 years and passes through 3 companies; a new generation was cleared every 16.3 years on median.
  • 1 of the 7 ancestors has a recall of any class.
  • Of its descendants, K120871 (Smith & Nephew, Inc., 2012) has gone furthest, with 6 descendants of its own.
  • 18 other devices also cite its predicate K994143.

How does its category compare?

All KTT devices

KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · KTT

10in 2025

2007: 92008: 112009: 112010: 122011: 102012: 92013: 72014: 142015: 122016: 102017: 112018: 62019: 82020: 92021: 102022: 32023: 72024: 52025: 102026 (partial year): 5
2007high 14 (2014) · low 3 (2022)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KTT

88in 2025

2007: 55 days median2008: 73 days median2009: 94 days median2010: 148 days median2011: 157 days median2012: 140 days median2013: 87 days median2014: 129 days median2015: 60 days median2016: 142 days median2017: 184 days median2018: 149 days median2019: 110 days median2020: 200 days median2021: 83 days median2022: 25 days median2023: 29 days median2024: 90 days median2025: 88 days median2026 (partial year): 68 days median
2007high 200 (2020) · low 25 (2022)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KTT

2in 2021

2007: 22008: 12009: 22010: 12012: 42013: 72017: 12018: 142019: 32021: 22026 (partial year): 11
2007high 14 (2018) · low 0 (2011)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KTT

673in 2025

2007: 452008: 662009: 452010: 1212011: 1962012: 5272013: 8982014: 4452015: 4012016: 4002017: 4852018: 5972019: 8002020: 9422021: 9612022: 6272023: 5542024: 5232025: 673
2007high 961 (2021) · low 45 (2007)2025

MAUDE reports naming product code KTT, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007955245
20081173166
20091194245
2010121481121
2011101570196
201291404527
20137877898
2014141290445
201512600401
2016101420400
2017111841485
2018614914597
201981103800
202092000942
202110832961
20223250627
20237290554
20245900523
202510880673
202656811—

What is it indicated for?

The Smith & Nephew Rail System components are intended to be used on adult or pediatric patients as required and are intended to be used for fracture fixation (open and closed); fractures and 'disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction; pseudarthrosis of long bones; limb lengthening; infected fractures or non-unions; and correction of long bone deformities.

Components in the Smith & Nephew Rail System are for single use only.

Indications for use as stated in the FDA summary.

Also cleared against K994143

18 other devices cite the same predicate.

  • K223112MAVERICK Mini External Fixation SystemSmith & Nephew, Inc. · 2022
  • K221792Acute QC Strut and ComponentsSmith & Nephew, Inc. · 2022
  • K213874MAVERICK External Fixation SystemSmith & Nephew, Inc. · 2022
  • K210953SMART Taylor Spatial FrameSmith & Nephew, Inc. · 2021
  • K201253Modular Rail System, TAYLOR SPATIAL FRAME External Fixator, JET-X Fixator, ILIZAROV External Fixator, Other…Smith & Nephew · 2020
  • K130479Ilizarov Drill Tip WiresSmith & Nephew, Inc. · 2013

More from Smith & Nephew, Inc.

692 FDA decisions under this applicant name. See the company

  • K263348Q-FIX KNOTLESS All-Suture Anchor, 1.8mm, with one ULTRABRAID Suture, Blue; Q-FIX KNOTLESS All-Suture Anchor…Smith & Nephew, Inc. · 2026
  • K261462LANDMARK Total Knee SystemSmith & Nephew, Inc. · 2026
  • K261968Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981)…Smith & Nephew, Inc. · 2026
  • DEN250037TESSA Spatial Surgery System; INTELLIO Tablet (72205455)Smith & Nephew, Inc. · 2026
  • K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc. · 2026

Recent decisions in KTT

The KTT category page

  • K263083Response Ortho Smart Fixator - Hexapod SystemResponse Ortho Solutions, LLC · 2026
  • K254087MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction SystemSynthes (USA) Products, LLC · 2026
  • K260900DYNEX® External Fixation SystemsVilex, LLC · 2026
  • K260112QuikFix External Fixator: Knee-Spanning PackStabiliz Orthopaedics, Inc. · 2026
  • K253291Excelsior SystemBlue Ocean Global · 2026

https://510kreport.com/device/K090926 · printed Nov 6, 2026

Cite this page

510(k) Report. “K090926: Smith & Nephew Rail System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090926

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026